About This 510(k) Submission
K251352 is an FDA 510(k) clearance for the Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration), a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Codonics.Incorporated (Middleburg Heights, US). The FDA issued a Cleared decision on July 11, 2025, 72 days after receiving the submission on April 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.